Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease (EMINENT-CD)

May 21, 2026 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease : EMINENT-CD

Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Brest, France, 29200
        • Not yet recruiting
        • CHU de Brest - Hopital de la Cavale Blanche
        • Contact:
      • Clermont-Ferrand, France, 63003
      • Nîmes, France, 30029
        • Not yet recruiting
        • CHU de Nîmes Carémeau
        • Contact:
      • Paris, France, 75674
        • Not yet recruiting
        • Institut Mutualiste Monsouris
        • Contact:
      • Toulouse, France, 31059
        • Not yet recruiting
        • CHU de Toulouse - Hôpital Rangueil
        • Contact:
      • Valence, France, 26000
        • Not yet recruiting
        • CH de Valence
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with CD
  • ≥ 18 to ≤ 75 years-old
  • Symptomatic CD according to PRO-2 (stool > 3 or abdominal pain score > 1)
  • Transmural inflammation on baseline MRI (C-score > 0.5 in at least one segment)

Exclusion Criteria:

  • Prior exposure to anti-p19 biological therapy
  • Exposure to more than 1 class of advanced therapies at a dose approved for the treatment of Crohn's disease (janus kinase [JAK] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents
  • Exclude any previous use of p19 IL23s agents
  • Contra-indication to mirikizumab
  • Definitive ostomy
  • Colectomy with IPAA
  • Isolated or uncontrolled perianal lesions
  • Severe obstructive symptoms
  • Intra-abdominal abscess
  • Contra-indication to MRI
  • No health insurance
  • Pregnant or lactating women
  • Patients already included in biomedical research other than an observational study (e.g., registry, cohort)
  • Concomitant Clostridioides difficile infection
  • HIV infection
  • Patient under guardianship, curatorship or safeguard of justice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mirikizumab treatment

Mirikizumab will be used as scheduled in the drug label: induction with IV infusions (900 mg) at week 0, week 4 and week 8.

For clinical responders: SC injections (300 mg) at W12 and every 4 weeks For clinical non-responders: SC injections (300 mg) at W12 and every 4 weeks
Drug: Mirikizumab - IV
Mirikizumab induction with IV infusions (900 mg) at week 0, week 4 and week 8.
Drug: Mirikizumab - SC
SC injections (300 mg) at W12 and every 4 weeks For clinical responders and non-responders

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Transmural response (TR25)
Time Frame: From week 0 to week 24
Transmural response (TR25) define as the decrease of at least (>=) 25% of C-score in each and all active segment from baseline to week 24
From week 0 to week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical remission
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76
Clinical remission will be defined according to PRO-2 (Patient Report Outcome)
Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76
Improvement or normalization of bowel urgency
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76
Improvement or normalization of bowel urgency according to UNRS (Urgency Numerical Rating Scale)
Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76
BU clinical meaningful improvement
Time Frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76
BU clinical meaningful improvement was defined as decrease of >=3 points; BU Remission was defined as UNRS =<2
Week 0, Week 4, Week 8, Week 12, Week 24, Week 52, Week 76
Transmural response (TR50)
Time Frame: Week 0, Week 24, Week 76
Transmural response (TR50) is defined as a decrease of at least 50% of C-score in each active segment at baseline
Week 0, Week 24, Week 76
Transmural healing
Time Frame: at Week 0, Week 24, Week 76
Transmural healing is defined as a C-score < 0.5 in each active segment at baseline
at Week 0, Week 24, Week 76
Disease activity
Time Frame: Week 0, Week 24, Week 76
Disease activity is measured by the MaRIA score (Magnetic Resonance Index of activity)
Week 0, Week 24, Week 76
IUS transmural response/healing
Time Frame: Week 4, Week 8, Week 12, Week 24
IUS transmural response/healing
Week 4, Week 8, Week 12, Week 24
Bowel damage
Time Frame: Week 24, Week 76
Bowel damage is measured with the Lemann Index
Week 24, Week 76
Transmural response (TR25)
Time Frame: Week 0, Week 4, Week 24, Week 76
Transmural response will be defined as a decrease of at least 25% of C-score in each active segment at baseline
Week 0, Week 4, Week 24, Week 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guillaume LE COSQUER, MD, CHU de Toulouse- Hôpital Rangueil
  • Principal Investigator: Anthony BUISSON, MD, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GETAID-2025-02
  • 2025-521889-95-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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